Safety and Efficacy of TrueTear™ for the Treatment of Meibomian Gland Disease



Status:Completed
Conditions:Ocular
Therapuetic Areas:Ophthalmology
Healthy:No
Age Range:22 - Any
Updated:10/12/2018
Start Date:July 26, 2017
End Date:October 29, 2017

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Prospective, Open-Label, Randomized, Proof of Concept Study Exploring Application of TrueTear™ for the Treatment of Meibomian Gland Disease

This study will compare the safety and efficacy of TrueTear to standardized moist heat
compress (Thermalon® Dry Eye Compress) for the treatment of Meibomian Gland Disease (MGD).


Inclusion Criteria:

- Dry eye disease or Meibomian Gland Disease as evaluated by Standard Patient Evaluation
for Dryness (SPEED) score, Schirmer test, Tear film breakup time and other applicable
objective measures at the Screening and Baseline Visits

- Use of an artificial tear product, lid hygiene, omega-3 supplementation, antibiotics
for the treatment of dry eye disease or Meibomian Gland Disease within one year of the
Screening Visit

Exclusion Criteria:

- Chronic or recurrent epistaxis, coagulation disorders or other conditions that may
increase the risk of bleeding

- History of nasal or sinus surgery

- Vascularized polyp, deviated septum or severe nasal airway obstruction at the
Screening visit

- Intraocular and extraocular surgery in either eye within three months of the Screening
Visit or refractive surgery within twelve months of the Screening Visit

- Cardiac demand pacemaker, implanted defibrillator, or other active implanted metallic
or active implanted electronic device in the head
We found this trial at
1
site
Andover, Massachusetts 01810
?
mi
from
Andover, MA
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